Atraumatic circumcision device and method to use same

ABSTRACT

A disposable neonatal circumcision device that secures the foreskin of the penis in a precise location, applies radially circumferential clamping, and delivers a longitudinal circumferential cutting device along the path precisely controlled by the device itself, not the operator, ensuring the incision to the clamped foreskin is made in the precise location, independent of the operator.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims benefit of U.S. Provisional ApplicationSer. No. 60/583,259, entitled “ATRAUMATIC CIRCUMCISION RING AND METHODin” filed on Jun. 25, 2004, which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention is related generally to the field of circumcision,and more particularly to a method and device for neonatal circumcisionenabling surgical removal of the excess foreskin or prepuce from theneonatal penis by a non-traumatic approach, eliminating the need for thetraditional dorsal slit.

BACKGROUND OF THE INVENTION

Newborn circumcision is the most commonly performed surgical procedurein the United States with over 1 million circumcisions performedannually. Circumcisions have been performed for centuries for bothreligious and medical reasons. Various instruments have been developedto help facilitate removal of the foreskin from the penis. Theseinstruments were intended to provide some level of hemostasis to helpcontrol bleeding, to provide a uniform cutting surface, and to protectthe underlying glans penis from trauma associated with the procedure. Ofthese devices, three are commonly used for neonatal circumcision in theUnited States: U.S. Pat. No. 119,180 ('180) by A. A. Goldstein, U.S.Pat. No. 2,747,576 ('576) by H. Bronstein, and U.S. Pat. No. 2,272,072('072) by C. J. Ross and U.S. Pat. No. 3,056,407 ('407) by D. H. Kariheret al.

One shortcoming of all the prior art is that a dorsal slit in theforeskin is required. In a neonate, the opening of the foreskin at thetip of the penis is small and tight. A dorsal slit is made to freeadhesions or separate the foreskin from the penis, allow enough room toaccommodate a cutting surface, and to facilitate alignment of a cuttingtool. This procedure causes a traumatic incision to be made on thedorsal surface of the foreskin, perpendicular to and unrelated to thefinal incision. In order to create the dorsal slit, considerable traumais exerted to the foreskin and to the neonate.

In order to initiate the dorsal slit, it is necessary to grasp theforeskin. In practice, this is routinely done with two hemostats thatare used to clamp and crush the distal foreskin at the ten o'clockposition and the two o'clock position. By clamping and thereforecrushing the foreskin, the surgeon is able to apply counter tractionwith one hand holding both instruments, while the surgeon uses the freehand to manipulate a third, straight hemostat to probe under theforeskin and then crush along the dorsal aspect. Scissors are used tocut the dorsal slit where the tissue was crushed. In order to create thedorsal slit, the foreskin of the newborn infant is unnecessarily crushedmultiple times and cut.

Studies published by the American Academy of Pediatrics state that amajority of circumcisions are done without any form of anesthesia. Thedorsal slit incision accounts for a significant amount of the pain andtrauma associated with a circumcision. In addition, the dorsal slit canbe a source for significant bleeding and possible infection.Additionally, the Food and Drug Administration (FDA) regularly reportscases where when attempting to perform the dorsal slit the surgeoninadvertently inserts the tip of the scissors into the urethral meatusand cuts not only through the foreskin but the glans penis itself.

The most commonly used neonatal circumcision clamp is described in U.S.Pat. No. 119,180 ('180) by A. A. Goldstein (referred to herein as theGomco). It consists of a metallic bell that is used to cover the glansor head of the penis to provide protection. After the dorsal slit ismade as described above, the foreskin is pulled over the bell and thebell is advanced upward through a hole that serves as a clampingsurface. A fulcrum and a screw nut are used to apply a force between theclamp and the bell, which crushes the foreskin and serves to helpcontrol bleeding during the incision. One of the shortcomings of theGomco is the difficulty to pull the foreskin up through the clampbecause of the small hole and the size of the clamp. It is a commonpractice for surgeons using the Gomco to use a common safety pin topierce the foreskin of the penis on either side of the dorsal slit tohold the foreskin together and to facilitate pulling the foreskin intothe clamp. Piercing the foreskin twice with a sharp, large needlegenerates unnecessary pain and increases the possibility of bleeding andtraumatic complications. Yet another shortcoming of the Gomco is thatthe bell is separate from the clamp making it possible to use the wrongsize bell with the wrong size clamp. Traumatic complications, includingpenile amputations, have been caused because of this mismatch of belland clamp. Furthermore, it is awkward to manipulate the large clamp andto attempt to pull the foreskin through the small bell opening whileengaging the clamping mechanism. Lastly, the final incision is made withthe free hand of the surgeon with a conventional scalpel attempting tocut around the bell. This procedure imposes a possibility of inadvertentplacement of the scalpel in the wrong position with associatedcatastrophic outcomes, such as penile amputation.

Another commonly used circumcision device is described in U.S. Pat. No.2,272,072 by Ross and U.S. Pat. No. 3,056,407 by Kariher et al.(referred to herein as the Plastibell), which also requires thetraumatic dorsal slit. The Plastibell employs a plastic bell that istied off with a string in a form of tourniquet. The remaining foreskinis trimmed with scissors. The plastic handle of the bell is broken offand the plastic bell stays in place until the foreskin necrosis andfalls off. The most reported complication of the Plastibell is increasedinfections due to the foreign body nature of the plastic bell, string,and necrotic tissue. Many parents object to this method, because they donot want to have to worry about the plastic bell that stays in place forup to 5 days following the circumcision. Another shortcoming is that thestring can be cut inadvertently by the surgeon performing thecircumcision causing excessive bleeding. The string can also be tiedwith insufficient applied pressure to prevent bleeding. As with theGomco, the chance for damage to the urethral opening of the glans ispossible because the surgeon makes the incision with scissors. Lastly,it is very difficult and awkward to simultaneously hold the plastic bellin place, keep the foreskin together, and tie a knot in the string atthe precise location on the plastic bell.

Yet another circumcision device is described in U.S. Pat. No. 2,747,576('576) by H. Bronstein (referred to herein as the Mogen clamp). TheMogan clamp is used less frequently because it is difficult to ensurethat excessive foreskin or the head of the penis has not beeninadvertently pulled up into the clamp. If the head of the penis isinadvertently pulled up into the clamp, the resulting clamping andincision causes an amputation of the tip of the penis. The FDA hasissued several warnings regarding this shortcoming of the Mogen clamp.Furthermore, the cosmetic outcome is often that the remaining foreskinis lopsided and asymmetric because the incision is made in a lineardirection and the underlying tissue has a circumferential orientation.

In August of 2000, the FDA released a cautionary statement regarding theGomco and Mogen type clamps. The FDA reported receiving 105 reports ofinjuries involving circumcision clamps between the months of July 1996and January 2000 or approximately 30 injuries per year. Assuming asimilar injury rate for the preceding 54 years, when these devices wereinitially introduced, they have likely accounted for well over 1600traumatic outcomes. Those incidents reported by the FDA includedlacerations, hemorrhages, penile amputations, and urethral damage.

U.S. Pat. No. 3,072,126 by P. M. Fenton ('126) discloses the use of anaxial circular cutting means to apply hemostasis compression to theforeskin as well as to cut the foreskin. The axial compression forceapplied by the circular cutting means to crush the foreskin invariablystretches and deforms the foreskin. As the circular cutting means isengaged, the foreskin is frequently and inappropriately pushed down overthe bell or tube making it difficult to predict the length of foreskinto be removed. Since the same surface is used to cut the foreskin aswell as to create the hemostatic crush to the foreskin, it would bedifficult to ensure that the foreskin is not inadvertently cut prior tothe application of enough compressive pressure to achieve hemostasisleaving the possibility of dangerous bleeding complications. Further,'126 requires use of a bell or tube to shield the glans, necessitatingthe inherent need for a dorsal slit to be made in the foreskin tofacilitate the placement of the foreskin on to the bell or tube.

U.S. Pat. No. 3,473,533 by J. C. Freda ('533) discloses the use of anaxial circular cutting means to cut the foreskin after an axiallyapplied force creates a compressive force for hemostasis. The axialcompression force to crush the foreskin invariably stretches and deformsthe foreskin as the clamping member is applied. As the clamping memberis engaged, the foreskin is frequently inappropriately pushed down overthe bell or tube making it difficult to predict the length of foreskinto be removed. The incision to the foreskin is made independent of thecrush which leaves open the dangerous possibility that an operator caninadvertently administer the cut without having first clamped theforeskin to create hemostasis. Further, '533 requires use of a bell ortube to shield the glans, necessitating the inherent need for a dorsalslit to be made in the foreskin to facilitate the placement of theforeskin on to the bell or tube.

A particular shortcoming shared by the prior art references is that nonedisclose a means to prevent the possibility of mismatched parts. Thepossibility of mismatched equipment or the use of a small shield with alarge clamp has caused dangerous catastrophic outcomes as regularlyreported by the FDA. These injuries are severe and include lacerationsand penile amputations.

SUMMARY OF THE INVENTION

The present invention generally includes two cooperating components: aring component and a clamping-cutting device. One embodiment of the ringcomponent includes an open circular ring mounted to one end of a shaft.One embodiment of the clamping-cutting device includes a plurality ofretractable arms operably connected to at least one movable lever arm.The clamping-cutting device also includes a cutting device (such as acircular blade) disposed within the clamping-cutting device, which isalso operably connected to a lever arm. The shaft of the ring componentmay include a notch in a predetermined location to engage theclamping-cutting device to ensure precise positioning of theclamping-cutting device in relation to the open circular ring. The opencircular ring may also include a circumferential groove along the outersurface of the open circular ring adapted to receive the edges of theretractable arms.

In operation, the ring component is manipulated between the foreskin andthe penis and positioned just above the glans of the penis. The openring allows insertion of the ring component into the foreskin withoutmaking a dorsal slit. This provides the placement of a clamping andcutting surface within the foreskin without making the unnecessary andtraumatic dorsal slit. Once the open ring is placed within the foreskinwithout making a dorsal slit, the clamping-cutting device is placed ontothe shaft of the ring component. The clamping-cutting device is thenactivated by moving the lever arm from the open to closed position. Asthe lever arm is moved downward or toward the closed position, theclamping-cutting device is moved over the plurality of retractable armscausing the arms to move radially inward to the closed position exertinga lateral, symmetric clamping force to the ring that serves to crush theforeskin. By exerting a lateral, symmetrical force, no manipulation ordeformation of the foreskin has to occur to get it into the clamp. Thering is positioned within the foreskin and remains in that locationuntil the lateral clamping force is applied. There is no need to pull ormanipulate the foreskin to get it into the clamp. The clamp is deliveredlaterally and symmetrically to the foreskin and ring so there is nodeformation to the foreskin prior to it being crushed, ensuring a moreprecise, reproducible, and predictable circumcision. In the closedposition, the plurality of retractable arms close on to and engage theopen circular ring, thereby closing the ring and crushing or clampingthe foreskin against the now closed circular ring. At the moment thecrush occurs, the foreskin remains in its anatomically correct position,improving the likelihood the physician can accurately determine thecorrect amount of foreskin to remove. Continued movement of the leverarm advances the cutting device towards the circular ring that cuts theforeskin clamped between the retractable arms and the circular ring.

One aspect of the present invention adapts a cutting device (such as ablade) to an actuator such that the cutting device translates parallelwith the shaft of the penis when cutting the foreskin. The mechanicalactuation of the cutting device provides an improvement in the controlof the position of the cutting device relative to the shaft of thepenis. The cutting device preferably translates along the common axis ofthe actuator which in turn translates along the common axis of the shaftof the ring component. The shaft of the ring component facilitatestranslation of the clamping-cutting device along the common axisproviding control of the positioning and alignment of the cutting devicewith the compression and cutting surface of the ring component. Theposition of the shaft in relation to the compression and cutting surfaceis fixed such that the cutting device can only reach the exact locationof the cutting surface, protecting surrounding tissue and eliminatingany chance of inadvertent damage to the penis from the cutting blade.The blade is an integral part of the device, the incision can not bemade until the housing has closed the retractable arms ensuring adequateclamping and crushing. The path of the blade is precisely controlled bythe device itself, not the operator, ensuring the incision is made inthe precise location, independent of the operator. The design of thepresent invention essentially eliminates the possibility of making anincision without having adequately crushed the foreskin. With thisdevice, the timing of the crush and cut is precisely controlled, theincision can not occur without first crushing the foreskin.

Another aspect of the present invention is that the blade is containedand protected within the device itself, essentially eliminating thechance of inadvertent trauma to surrounding structures.

Another aspect of the present invention is that the internal shape ofthe opening of the clamping-cutting device can be made such that it canonly mate with an appropriate ring. Anatomic variation requires devicesof different size. This requires different size housings and differentsize rings. In order to completely eliminate the chance of usingmismatched parts, the housing and ring will be uniquely mated, so thatonly the exact housing can be used with a particular sized ring. Thismechanical specification will eliminate any chance of a userinadvertently using the wrong size ring with the wrong sizeclamping-cutting device. The design of this invention eliminates thepossibility of mismatched parts and their potential catastrophicoutcomes.

Another aspect of the present invention is that the open ring can bemade to interact with the clamping-cutting device such that a mechanicalstop can be used to control when and how the levers are activated. Byusing a mechanical stop, the two parts can be designed such that thelever arms can not be activated unless the clamping-cutting device ispositioned in the exact position on the ring that inhibits themechanical stop. This type of interaction can ensure that theclamping-cutting device can only be placed on the ring when in the openposition, and the lever arms can only be activated when theclamping-cutting device is in the exact position on the ring.Furthermore, the design makes it impossible to move the housing once thelever arms have been activated, eliminating the chance of the operatorpulling off the housing prior to completion of the crushing and theincision. The design ensures that the only way the operator can put theclamping-cutting device on the shaft of the ring is in the openposition, eliminating the chance of the operator erroneously putting theclamping-cutting device on in the closed position. Furthermore, thedesign eliminates the chance of the operator activating the lever armsbefore the clamping-cutting device is in the exact location. It can alsoeliminate the chance of the clamping-cutting device moving at all alongthe shaft once the lever arms have been activated. The mechanicalcontrol of these important procedural elements ensures a reproducible,risk free circumcision, independent of the operator.

It is an object of the present invention to provide a device to easilyperform newborn circumcision, shorten the operation time, producereliable and consistent outcomes, and substantially eliminate the riskof human error and catastrophic outcomes.

It is a further object of the present invention to provide a device toperform neonatal circumcision that eliminates the need for thetraditional dorsal crush and slit, thereby minimizing bleeding andsignificantly reducing the trauma and pain associated with theprocedure.

It is a further object of the present invention to provide a device thatdelivers a lateral, symmetrical clamping force to the foreskin and thering thereby eliminating the need to pull or manipulate the foreskin toposition it in the clamping means.

It is a further object of the present invention to provide a device thatfacilitates the use of a circular cutting device that is deliveredlongitudinally to the shaft of the penis and performs a singlecircumferential and uniform incision.

It is a further object of the present invention to provide a device thatintegrates and encloses the circular blade within the device such thatthe device itself provides precise control over the delivery of thecutting surface while protecting the patient and user from inadvertentinjury, essentially eliminating the chance of user error andcatastrophic complications.

It is a further object of the present invention to provide a device thatadapts a mechanical means to control the crushing of the foreskin andthe delivery of the blade, ensuring that the incision can only be madeafter the foreskin has been sufficiently crushed.

It is a further object of the present invention to provide a mechanicalmeans that completely eliminates the chance of mismatching differentsized parts, eliminating the chance of a ring component being used withthe wrong sized crushing-cutting device.

It is a further object of the present invention to use a lever arm withsemicircular gears and a gear track to activate device.

It is a further object of the present invention to have the ability tomanufacture each of the non-cutting surface parts out of plasticmaterials allowing the device to be disposable or recyclable for onetime use, eliminating the need for autoclaving, reducing the risk ofmismatched parts, and reducing the risks associated with using worn ordamaged parts.

It is a further object of the present invention for the various sizedparts to be made in differing colors based on size to assist users inidentifying appropriate parts and appropriate sizes, expediting theprocedure, and further avoiding the chance of mismatched parts.

It is a further object of the present invention to incorporate amechanical means or lever locking system that ensures the levers thatactivate the device can only be activated when precise alignment of thering and the clamping-cutting device has been achieved. And suchmechanical means ensures the position of ring and clamping-cuttingdevice is maintained throughout the actuation of the device.

It is a further object of the present invention to generate an audiblesound when the lever arms have been successfully actuated to inform theoperator that the crushing and cutting actions have been completed.

For a better understanding of the present invention, together with otherand further objects thereof, reference is made to the accompanyingdrawings and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is illustratively shown and described in referenceto the accompanying drawings, in which:

FIG. 1 is an exploded view of the present invention;

FIG. 2 is a cross-section of the present invention of FIG. 1 in theopened or relaxed position;

FIG. 3 is a cross-section of the present invention of FIG. 1 in theclosed or engaged position;

FIG. 4 is a pictorial view of one embodiment of the clamping-cuttingsurface apparatus of the present invention;

FIGS. 5, 6, 7, and 8 are pictorial views of the clamp-cutting apparatusbeing inserted into the foreskin of the neonatal penis;

FIG. 9 are pictorial views illustrating use of the present invention;

FIGS. 10, 11, and 12 are cross sectional views of various embodiments ofthe present invention illustrating insertion of various sizedclamp-cutting surface apparatus into a clamping-cutting device

FIGS. 13 and 14 are pictorial views of an alternative embodiment of thepresent invention;

FIGS. 15 and 16 are cross section views of another alternativeembodiment of the present invention;

FIG. 17 is a cross section views of yet another alternative embodimentof the present invention;

FIG. 18 is an exploded view of the alternative embodiment of FIG. 17;

FIG. 19 is a cross section views of yet another alternative embodimentof the present invention; and

FIG. 20 is an exploded view of the alternative embodiment of FIG. 19.

DETAILED DESCRIPTION OF THE INVENTION

One aspect of the present invention 100, illustrated in FIGS. 1, 2, and3, includes ring component 1 and clamping-cutting device 102.Clamping-cutting device 102 includes operably connected housing 2,clamping member 3 with retractable arms 3F, blade holder 4 with integralblade 8, gear track 5, and two lever arms 6. Clamping member 3 isoperably connected to lever arms 6 such that when lever arms 6 areactuated up retractable arms 3F are positioned out of clamping-cuttingdevice 102 to the opened or resting position (FIG. 2) or when lever arms6 are actuated down the clamping-cutting device 102 traverses over theclamping member 3 to the closed or engaged position (FIG. 3).

In the open position (FIG. 2), the ring component 1 is free to move intoand out of clamping-cutting device 102. As lever arms 6 move downward tothe closed position (FIG. 3), retractable arms 3F of clamping member 3radially close and apply substantially even circumferential pressure toopen ring 1D of the ring component 1 to firmly close the ring 1D andhold the ring component 1 in place as the housing 2 of theclamping-cutting surface 102 is advanced over the retractable arms 3F.In the clamped configuration, the ring component 1 and theclamping-cutting device 102 act as a single, integral componentcontrolled by the actuation of level arms 6. Downward progress ofcrushing-cutting component 102, a distance designated B, advanceshousing 2 over retractable arms 3F such that the clamping operation isfully activated or engaged. At the moment the housing 2 has beenadvanced the distance B and the crush has been completed, the blade hastraveled the same distance B and is positioned above the ring andcutting surface. It is not until the lever arm 3 has been furtheractuated and the housing 2 and blade 8 have been advanced further downclamping member 3 a distance designated A that the cutting edge 8A isbrought into contact with the cutting surface 1C of ring 1D therebyincising the foreskin positioned between the cutting edge 8A and thecutting surface 1C. During further advancement of housing 2 over theretractable arms the crushing force of retractable arms 3F aremaintained by the inner diameter of the housing 2. The timing of thecrush and cut is controlled by distances A and B. These distances aresufficiently different to ensure that the clamping action occurs priorto the incision. And more importantly, that an incision can not possiblybe made without first activating and maintaining the clamping action.Downward progress A of crushing-cutting component 102 stops when thecutting edge 8A of blade 8 contacts the top or cutting surface 1C ofring 1D of the ring component 1. The sequence of the crush and cut iscontrolled by the device itself when the operator actuates the leverarms downward fully in one single motion. As lever arms 6 are actuated,the present invention clamps the foreskin radially to create asubstantially symmetrical and even circumferential hemostasis at theaxial position and at the same time as the motion continues and onlyafter the crush has occurred, delivers the cutting edge of blade 8 tothe cutting surface 1C of the ring 1D completing the incision slightlyabove where the clamping member 3 crushed the foreskin and achieved thehemostasis affect. The incision to the foreskin is made while theforeskin is within housing 2 and can be out of the direct line of sightof the operator if housing 2 is made of a non-transparent material orcolored.

Housing 2 is generally cylindrical, hollow, and vertically longitudinalhaving an top portion 2B and a bottom portion 2C. Housing 2 includes topportion 2B, bottom portion 2C, opposing slots 2D, through bore 2E, topopening 2F, bottom opening 2G, assembly hole 2H, and two pairs ofprojections 2I. Bore 2E includes a sufficiently sized inner surface andlength to receive therein clamping member 3, blade holder 4, gear track5, and ring component 1.

Two lever arms 6 are pivotally joined to top portion 2B about a pivotalaxis. Each lever arm 6 has a predetermined length and width sufficientto sustain the forces of clamping and cutting. Semi-circular gears 6Aare adapted to the distal end 6B of each lever arm 6 and a handle at theother end. Lever arms 6 are positioned on opposite sides of top portion2B of housing 2 and positioned such that a portion of semi-circular gear6A extends through a slot 2D in housing 2 so as to engage gear track 5within housing 2. Each semi-circular gear 6A includes a plurality ofgear teeth 6C. Width of lever arms 6 are sized to fit between pair ofprojections 2I and are pivotally attached to projections 2I by aconventional joining device (not shown) such as bolt/nut or bushing orpressed fit pin connection. Each projection 2I may include hole 2J toreceive the conventional joining device. Each semi-circular gear 6A mayinclude a through bore 6D to receive the conventional joining meanstherethrough pivotally connecting each lever arm 6 and projection 2Iwith one conventional joining means. Alternatively, two conventionaljoining means can be inserted through each projection 2I intosemi-circular gears 6A, either with or without a through bore, to formthe pivotal connection. Projections 2I act as a pivotal axis for leverarms 6 and allow lever arms 6 to rotate or pivot about an axis. Pivotalmovement of lever arms 6 causes rotation of semi-circular gears 6A toimpart reciprocating movement to gear track 5. Semi-circular gears 6Ahave a diameter that is sufficient to linearly move housing 2 up anddown over retractable arms 3F.

Bottom opening 2G of bottom portion 2C of housing 2 has an insidediameter that is made to accommodate the top portion of clamping member3. As housing 2 is advanced down over clamping member 3, the insidediameter of housing 2 causes retractable arms 3F of clamping member 3 toradially close, such that when housing 2 is advance completely overclamping member 3, retractable arms 3F are closed and in a position toengage open ring 1D and exert a significant compressive force on groovedouter surface 1F of open ring 1D.

Gear track 5 includes a plurality of gear teeth 5A evenly spaced alongthe length of gear track 5. Gear track 5 further includes through radialhole 5B for connecting clamping member 3 to gear track 5 (disclosed indetail below). Gear track 5 is initially positioned within top portion2B of housing 2 and is capable of axial movement within housing 2 ineither longitudinal direction. Gear teeth SA of gear track 5 cooperatewith gear teeth 6C of semi-circular gears 6A to translate gear track 5axially within bore 2E of housing 2. Gear track 5 has a verticalpassageway 5C extending through its axial center that is sized toreceive only the narrow portion of shaft 1A of ring component 1. Byaccommodating only the narrow part of shaft 1A, bottom face 5D contactsor rests on notch, ledge or shoulder 1G of shaft 1A, and thereforealigns the clamping-cutting device 102 with ring component 1 and openring 1D (discussed in detail below). Shoulder 1G can be formed by shaft1A having two sections with different diameters: an upper section 1Jhaving a diameter smaller than diameter of 5C and a lower section 1Ahaving a diameter larger than diameter of 5C. Gear track 5 is freelyrotatable about its axis and gear teeth 5A extend circumferentiallyaround gear track 5. The contact at any given time between gear teeth 6Cof semi-circular gear 6A and gear teeth 5A on gear track 5 is limited toa single tooth and preferably a single point contact.

Blade holder 4 includes circular blade 8 and blade support 4A. Circularblade 8 and blade support 4A are connected by conventional meansincluding, for example, snap fit, press or interference fit, cooperatingmale/female threaded members, screw, bolt, pin, weld, or adhesive. Bladesupport 4A includes longitudinal through bore 4B (disclosed in detailbelow). Blade support 4A may include retention hole 4C to connect bladeholder 4 to housing 2 with, for example pin 22. Further, blade holder 4has an outer diameter less then that of the inside diameter of clampingmember 3 such that blade holder 4 can move freely longitudinally withinclamping member 3. At the location of slot 3D in clamping member 3,blade holder 4 is affixed to housing 2 and moves simultaneously withhousing 2. Blade holder 4 and housing 2 are attached together and moveas one component. The attachment point occurs at the location of slot 3Dsuch that housing 2 and blade holder 4 can move independently ofclamping member 3.

Clamping member 3 is generally a hollow cylindrical member with lowerend 3A and upper end 3C. Clamping member 3 is freely moveable within thelower part of housing 2. The hollow center of clamping member 3 allowsfor the positioning and passing therethrough of blade holder 4. Clampingmember 3 includes a plurality of retractable arms 3F at lower end 3A.Upper end 3C is defined by two extensions 3B positioned on oppositesides of the cylinder at upper end 3C. Pair of extensions 3B are adaptedto form slot 3D. Slot 3D is sized to receive blade holder 4 and geartrack 5. Each extension 3B includes retention hole 3E for connectingclamping member 3 to gear track 5 with, for example, pin 23. Slot 3Dextends longitudinally along the cylinder and allows for fixation ofblade holder 4 to housing 2 (discussed in detail below) withoutinterfering with clamping member 3 ability to traverse within housing 2.Once clamping member 3 is fixedly attached to gear track 5, gear track 5drives housing 2 up and down over clamping member 3, thereby opening andclosing retractable arms 3F.

As discussed above, lower end 3A of clamping member 3 includes of aplurality of circumferentially evenly spaced, downwardly facing,outwardly tapered, flexible retractable arms 3F. Retractable arms 3F canbe made of elastic material, such as plastic, metal, graphite, or otherpolymer, that retains its spring-like characteristics. The ends ofretractable arms 3F form an opening 3G adapted to engage grooved outersurface 1F of open ring 1D. When the present invention is in the openedor relaxed position, opening 3G is larger then the outer diameter ofopen ring 1D. Retractable arms 3F extend outwardly in a tapered mannerallowing for an open position that allows for positioning of clampingmember 3 over the outside diameter of the upper section 1J of shaft 1A.As housing 2 is advanced down over retractable arms 3F, the insidediameter of housing 2 engages the tapered edge of retractable arms 3Fand results in the closure of retractable arms 3F. When retractable arms3F are closed, the ends of retractable arms 3F define an opening 3G thatis substantially the same diameter as the outer diameter of open ring 1Dwhen gap 1E of open ring 1D is closed. Retractable arms 3F, when closed,cooperate with grooved outer surface 1F of open ring 1D to crush theforeskin for a hemostasis effect and hold open ring 1D in a secure,fixed position prior to the delivery of the axial force of blade 8 tothe prepuce foreskin.

As discussed above, retractable arms 3F are fully extended or opened inthe unrestrained condition, thereby forming the largest opening diameter3G possible. As retractable arms 3F are drawn axially into, for example,housing 2, retractable arms 3F move radially inward, thereby reducingthe diameter of opening 3G. Retractable arms 3F are adapted to engagedring component 1, crush the foreskin, and restrain the movement of ringcomponent 1. Each retractable arm 3F may include inward radial extension3H, which is preferably curved to fit the contour of grooved outersurface 1F, to further enhance the hemostasis effect. Four retractablearms are illustrated, however, any number of arms are acceptable thatachieve the desired results discussed in detail below.

One embodiment of the clamping-cutting device 102 can be assembled byaligning retention hole 3E of clamping member 3 with radial hole 5B ofgear track 5. A conventional means such as a screw, bolt, or press-fitpin 23 is inserted through retention hole 3E and radial hole 5B of geartrack 5, thereby connecting together clamping member 3 and gear track 5.Blade holder 4 is place within the assembled clamping member 3/geartrack 5 and the entire assembly is positioned within through bore 2E ofhousing 2. Retention hole 4C of blade holder 4 is aligned with assemblyhole 2H of housing 2. A conventional means such as a screw, bolt, orpress-fit pin 22 is inserted through retention hole 4C of blade holder 4and assembly hole 2H of housing 2, thereby connecting together housing 2and blade holder 4. Each lever arm 6 is positioned between pair ofprojections 21. Semi-circular gears 6A are extended into housing 2Athrough slot 2D. Gear teeth 6C of semi-circular gears 6A are positionedto engage gears 5A of gear track 5. A conventional joining device isadapted to pivotally attach lever arm 6 to projection 21, therebycompleting the assembly of clamping-cutting device 102.

Now turning to FIG. 4, ring component 1 is generally a single piece ofmalleable, elastic material (such as plastic) with an open ring 1Dmounted orthogonally to shaft 1A by curved member 1H, which allowsmanipulation of open ring 1D within the foreskin. Shaft 1 A includes aplurality of diameters to control the insertion of ring component 1 intoclamping-cutting device 102. A shaft diameter change can be delineatedby a notch or ledge or, as illustrated in FIG. 1, shoulder 1G that actsas a stop of ring component 1 into clamping-cutting device 102. Openring 1D includes a cutting surface 1C on its top surface being adaptedto act as a cutting surface when cutting edge 8A of blade 8 is presseddown against foreskin interposed between cutting surface 1C and cuttingedge 8A. Open ring 1D may also include grooved outer surface 1F adaptedto engage with inward radial extension 3H of retractable arm 3F to holdring component in a stationary position relative to housing 2 during theclamping/cutting operation, such that the foreskin is trapped betweenthe grooved outer surface 1F and the retractable arms 3F. Further,grooved outer surface 1F will interact with inward radial extension 3Hto crush the foreskin against open ring 1D and contemporaneously holdring component 1 in position while circular blade 8 is delivered to makethe incision in the foreskin. Open ring 1D includes an opening or gap 1Elarge enough to allow the thickness of the foreskin to enter. The innerdiameter of the open ring 1D is large enough to receive a predeterminedsized glans and shield the glans or head of the penis from being clampedand/or cut.

FIGS. 5, 6, 7, and 8 demonstrate the insertion of open ring 1D into theneonatal foreskin 15. As discussed above, opening 1E allows entry ofopen ring 1D into foreskin 15. Foreskin 15 is held by an atraumaticforceps 13 while opening 1E is positioned to enter foreskin 15. With apair of non-traumatic forceps, the foreskin is gently grasped andforeskin 15 is guided into the narrow gap 1E of open ring 1D. With ascrew-like motion of shaft 1A of ring component 1, the open edge of openring 1D is advanced in, down, and around the inner aspect of theforeskin. The opening or gap 1E in open ring 1D allows the open edge tobe advanced into the foreskin with a smooth, non traumatic fluidscrewing motion. Once open ring 1D is fully inserted and resides justbeneath foreskin 15, it can be pushed down slowly toward the glans tofree any adhesions. Inside foreskin 15, opening or gap 1E is closed bythe elastic nature of the foreskin. The closed open ring 1D, inside theforeskin of the penis, residing just above the glans or tip of thepenis, is then used as the compressive surface for any number of clamps,such as inward radial extension 3H, and its top surface acts as acombination glans shield and or cut surface for blade 8 as it cuts theforeskin.

FIG. 9 illustrates the method of using the present invention to performa neonatal circumcision. Step A: Open ring 1D of ring component 1 isinserted into the foreskin of the penis, as discussed above. Step B:Clamping-cutting device 102 is set in the open position with lever arms6 rotated up and retractable arms 3F extending fully through the bottomof housing 2. Step C: Clamping-cutting device 102 is inserted onto shaft1A of ring component 1. Downward movement of clamping-cutting device 102and housing 2 onto shaft 1A is stopped when shoulder 1G contacts bottomface 5D of gear track. Step D: Lever arms 6 are activated downward toadvance housing 2 downward over retractable arms 3F causing the clampingforce and delivering the circular blade to the foreskin. Morespecifically, semi-circular gears 6A of lever arms 6 engage with gearteeth 5A of gear track 5 of clamping-cutting device 102. Housing 2 movesdownwardly over retractable arms 3F causing retractable arms 3F toradially close on to and to exert lateral compressive force against theforeskin. Retractable arms 3F exert sufficient lateral compressive forcesuch that inward radial extensions 3H of retractable arms 3F forces theforeskin into grooved outer surface 1F of open ring 1D, thereby clampingthe foreskin without any trauma or deformation between the ringcomponent 1 and the clamping-cutting device 102. As housing 2 isadvanced even further over the open ring 1D, blade 8 is delivered to thetop surface of open ring 1D and creates the circular incision into theforeskin when open ring 1D is within housing 2. Using the top surface 1Cof open ring 1D as the cutting surface that is held in place by theclosed retractable arms 3F, blade 8 makes a single, clean,circumferential incision on top of the ring, removing the excessforeskin. The clamp is left in place for a period of time ensuringadequate crushing and hemostasis. Step E: Lever arms 6 are lifted upwardand retractable arms 3F release ring component 1, lifting housing 2 ofthe clamping-cutting device 102 and lifting blade 8 back up into housing2 and releasing open ring 1D. Shaft 1A with severed foreskin is removedfrom housing 2. All components of the present invention and byproductsof the operation are thrown away, thereby completing the circumcision.

FIGS. 10, 11, and 12 illustrate how the present invention eliminates thechance of mismatched parts. In FIG. 10, smaller ring component 16 isshown inside larger housing 17. The location of the shoulder 10 on theshaft of ring component 16 prevents shaft from being inserted all theway into the housing 17. With open ring extending below retractablearms, clamping-cutting surface apparatus 16 and housing 17 are notengaged and blade may not cut foreskin. Therefore, the use of a smallerring component 16 with larger housing 17 is prevented.

FIG. 11 illustrates a proper fit between ring component 18 and housing17. Ring component 18 is the appropriate size for the housing 17 and theretractable arms 9 are perfectly aligned with the open ring 14. Ringcomponent 18 and housing 17 engage and blade cuts foreskin.

FIG. 12 illustrates how a larger ring component 19 interacts with asmaller housing 17. In this case, it is the diameter of the shaft ofring component 19 that prevents the shaft from being inserted intohousing 17. On the shaft of ring component 19, the location of theshoulder and the diameter of the shaft make up two variables that areused together to completely eliminate the chance that a wrong size ringcomponent could be used with a wrong size housing. Colored coded ringsthat match the appropriate size housing can be used to help usersidentify appropriate parts and appropriate sizes.

FIGS. 13 and 14 illustrate an alternative embodiment of theclamping-cutting device of the present invention having a lever-lockingsystem to ensure more accurate deployment of lever arms 6. Lever arm 6is in the up or open position aligning slot 21 in the pivotal axialshaft of the lever arm 6 that would allow lever arm 6 to be slid intoposition on the shaft 1. Because of slot 21, lever arm 6, in theposition shown, can not be deployed. Lever arm 6 is jammed or blockedfrom rotating because of the shaft.

In FIG. 14, lever arm 6 has been moved down shaft 1 and is aligned withcurved notch 20 in shaft 1. Curved notch 20 allows lever arm 6 to rotateto the down or closed position. The location of curved notch 21 in shaft1 ensures that lever arms 6 can only be deployed when theclamping-cutting device 2 is in the precise location on shaft 1.Furthermore, once lever arm 6 is deployed, lever arm 6 can not move upor down on shaft 1 because it becomes locked in place as a result of thecurved notch 21.

FIGS. 15 and 16 illustrate yet another alternative embodiment of theclamping-cutting device of the present invention in the open and closedposition. This embodiment incorporates a means to generate a clickingsound when the lever arm has moved a sufficient distance to ensureclamping and cutting. Elastic projection 24 of semicircular gear 6Amakes contact with projection 25 of the clamping member 3. As thesemicircular gear 6A rotates, elastic projection 24 is held byprojection 25 until semicircular gear 6A rotates a sufficient amountthat elastic projection 24 snaps free thereby striking surface 26 of theclamping member and making a distinct click. The position of the elasticprojection 24 on the semicircular gear 6A is such that the clickingsound occurs when the lever arm 6 is in the fully closed or downposition. The clicking sound provides an audible signal to the operatorthat the lever arm has been appropriately deployed and that the crushingand cutting is complete.

FIGS. 15 and 16 also demonstrate a clamping-cutting device that has ahousing 2 that is fixed to clamping member 3. Once in position on ringcomponent 1, the housing 2 of the clamping-cutting device 102 does notmove. Activation of lever arm 6 and semicircular gears 6A causesrotation about an axis fixed to housing 2. Rotation of the semicirculargears 6A activates reciprocating movement of an internal cylindricalsleeve 27 that moves within housing 2 and can be advanced over theclamping member 3 to close retractable arms 3F. The internal sleeve 27is fixedly attached to blade holder 4 allowing advancement of the sleeve27 to deliver the blade holder 4 and the cutting surface to ring 1D ofring component 1. FIG. 16 demonstrates sleeve 27 and blade holder 4 inthe up position, retracted into housing 2. FIG. 15 demonstrates sleeve27 and blade holder 4 in the down position, extending below housing 2,closing retractable arms 3F and delivering the cutting surface to thetop surface of the ring 1D.

FIG. 16 also demonstrates a clamping-cutting device that utilizes justone lever arm and demonstrates how the lever-locking system can be used.As shown if FIG. 16, the shaft 1A of the ring component 1 can only beinserted into the thru hole 2E of the housing 2 when the lever arm 6 isin the up position thereby aligning slot 21 vertically and allowingclearance for shaft 1A to traverse through thru hole 2E. Once the ringcomponent 1 is inserted into thru hole 2E of housing 2, the notch 21prevents rotation of the lever arms 6. FIG. 15 demonstrates how rotationof the lever arms can only be initiated when slot 20 of the ringcomponent 1 is aligned with notch 21 allowing rotation of the lever armsand activation of the clamping-cutting device. At the precise locationwhere notch 21 is aligned with slot 20, the ring component 1 is inperfect alignment with the clamping-cutting device 102. It is only whensuch precise alignment occurs that the operator is able to activate theclamping-cutting device.

FIGS. 17 and 18 illustrate other alternative embodiments of theclamping-cutting device of the present invention wherein aclamping-cutting device utilizes a threaded screw to advance the housingover the retractable arms.

FIGS. 19 and 20 illustrate yet other alternative embodiments of theclamping-cutting device of the present invention that uses one lever armand a lining system.

It will now be apparent to those skilled in the art that otherembodiments, improvements, details, and uses can be made consistent withthe letter and spirit of the foregoing disclosure and within the scopeof this patent, which is limited only by the following claims, construedin accordance with the patent law, including the doctrine ofequivalents.

1. A circumcision system for removing excess foreskin from the neonatalpenis comprising: a housing having a through bore; a radial clampingdevice having a plurality of longitudinal clamping arms, at least aportion of said radial clamping device being disposed within said boreof said housing; a axial cutting device having axially oriented blade,said axial cutting device being fixedly attached to said housing withinsaid bore, said axial cutting device having a cutting edge; a ringcomponent having a clamping surface adapted to engage said plurality oflongitudinal clamping arms and a cutting surface adapted to engage saidaxially oriented blade; an actuation mechanism being operably connectedto said plurality of longitudinal clamping arms to radially translatesaid plurality of longitudinal clamping arms inward to clamp said ringcomponent; and said actuation mechanism being operably connected to saidaxial cutting device to axially translate said cutting edge relative tosaid clamped ring component to cut the excess foreskin.
 2. Thecircumcision system according to claim 1 further comprising a cuttingdelay mechanism defined by an axial distance between said cutting edgeof said axially oriented blade and said cutting surface of said ringcomponent.
 3. The circumcision system according to claim 1 wherein saidactuation mechanism comprises: at least one lever arm with a pluralityof gear teeth disposed at its distal end, said at least one lever armbeing pivotally connected to said housing, at least a portion of saidplurality of gear teeth being disposed within said housing; a gear trackwith a plurality of gear teeth, said gear tracking being capable ofaxial translation within said housing; and said at least a portion ofsaid plurality of gear teeth of said at least one lever arm capable ofrotation engagement with said plurality of gear teeth of said geartrack, whereby said gear track translates axially in either directionwithin said housing when said at least one lever arm is actuated upwardor downward.
 4. The circumcision system according to claim 1 whereinsaid ring component further comprises an opening sufficiently sized toallow thickness of the foreskin to pass therethrough.
 5. Thecircumcision system according to claim 1 wherein said ring componentfurther comprises a grooved outer surface adapted to engage saidplurality of longitudinal clamping arms.
 6. The circumcision systemaccording to claim 1 wherein said ring component further comprises aninner diameter sufficiently sized to shield glans of the penis frominjury.
 7. The circumcision system according to claim 1 furthercomprising an audible device operably connected to said actuationmechanism to signal the operator that the clamping and cuttingoperations have been completed.
 8. The circumcision system according toclaim 1 wherein said cutting edge is a circular blade.
 9. Thecircumcision system according to claim 1 wherein said radial clampingdevice, said axial cutting device, and said actuation mechanism areoperably connected to said housing to form a clamping-cutting device.10. The circumcision system according to claim 9 further comprising anlocking system operably connected to said actuation mechanism to ensureprecise alignment of said ring component with said clamping-cuttingdevice has been achieved:
 11. The circumcision system according to claim9 wherein said ring component and said clamping-cutting device includesize indicia for matching said ring component with the appropriatelysized clamping-cutting device to avoid mismatched devices.
 12. Thecircumcision system according to claim 9 wherein: said ring componentfurther comprises a shaft attached to said ring component, said shafthaving at least one obstruction disposed at a predetermined along itslongitudinal length; and said clamping-cutting device further includingan opposing obstruction to stop the relative axial translation of saidshaft into said clamping-cutting device when said at least oneobstruction contacts said opposing obstruction, whereby said ringcomponent is juxtapositioned axially to said plurality of retractablearms when said ring component is matched with appropriately sizedclamping-cutting device.
 13. The circumcision system according to claim1 wherein said ring component, said housing, said radial clampingdevice, said axial cutting device, and said actuation mechanism are madesubstantially of polymer material, whereby allowing said circumcisionsystem to be disposable or recyclable and suitable for one time use.